How a change in uterine suturing lead to maternal deaths

How a change in uterine suturing lead to maternal deaths

After reading Ina May Gaskins book ‘Ina May’s Guide to childbirth’, I have been particularly interested in medical fiascos that are not widely known of. For myself and for all women, I think it’s important that we are fully informed of the benefits and risks of any drug or procedure that is offered to us so that we can make an informed decision about whether we would like it or not.

One particular experimental procedure that was introduced in the 1990s was single layer uterine closure. When women had a caesarean in the past, there was an extremely high risk of maternal mortality mainly due to doctors believing that the uterus should not be sutured. Since then they realised that in fact it should be, so they began to suture the uterus, using double layer sutures for over 80 years now.

In 1994, Michael Stark, a doctor at the Misgav-Ladach General Hospital in Jerusalem introduced a new experimental way of suturing with single layer closure instead of double at the FIGO conference in Montreal. He believed it would save time and result in a more efficient caesarean delivery with mothers able to get back to their usual self quicker. 

Indeed, the following studies support this method of suturing:

Study 1 - https://www.ncbi.nlm.nih.gov/pubmed/10796177

This study looked at two trials involving 1006 women and found that there were not major advantages or disadvantages over one or the other method except a shorter operating time. 

“Based on one trial, single layer closure was associated with reduced operating time (5.6 minutes). Based on one trial, radiographic scar appearance showed fewer scar defects at three months with the single closure group. There were no statistically significant differences in the use of extra haemostatic sutures, incidence of endometritis, decrease in post operative haematocrit or use of blood transfusion.” 

Study 2 - https://www.researchgate.net/publication/315383115_Single_Layer_Versus_Double_Layer_Closure_of_Uterus_during_Caesarean_Section_-_A_Prospective_Study_in_Index_and_Subsequent_Pregnancy 

This study performed on 357 women also looked at subsequent pregnancy and the impact of single vs double layer closure. It concluded that “Single layer closure was associated with lesser operating time, intra-operative blood loss, febrile morbidity and hospital stay in index pregnancy as compared to double-layer closure.” This was from March 2007 - January 2009. 

If I were a woman reading these studies and thinking about getting an elective C-section I would be all for single layer suturing. Great results from studies, no side effects – what more could I ask for right? Wrong. As Ina May points out in her book Ina May’s Guide to Childbirth, there was limited testing on this method, and there was also a change in material used from silk sutures to removable cat gut sutures. The most dangerous part of these studies is that they did not consider the impact of single layer sutures on future pregnancies.

Ina May states that single layer suturing - also called the Misgav-Ladach method has come into vogue in the United States. In 1999 at an annual conference of the National Association of Childbearing Centres, a pathologist Dr Kurt Benirscheke said that this new single layer suture may have resulted in the increase in placenta problems he had seen in the last few years. Placenta percenta is a dangerous complication where the placenta grows over the uterine scar from a previous c-section and through the tissue into other organs like the bladder. In a single layer suture, the uterine muscle does not grow back as much as a double layer suture, meaning that the placenta which normally embeds itself into the uterine lining could grow over the scar and through the minimal muscle that has been regenerated and invade other organs. 

Through his entire career, he had never seen cases of placenta percenta, but moving from his hospital in Boston to San Diego he saw 10 cases per year for three years. The incidence was supposed to be 1 in 12,5000 births but it was a lot higher in San Diego and Dr Benirscheke suggested it was due to single layer suturing being the prefered method there. 

Another study mentioned in Ina May’s Guide to Childbirth is a study in Montreal of 2,142 women, comparing a single layer suture to double layer where they found that there was a four times higher risk of uterine rupture with the single layer method. After this study, chairman of Maternal Fetal Medicine at a hospital centre in Yale decided that they would not do any single layer suturing of the uterus until there are more studies and evidence it was safe. Ina May was personally told of four deaths related to single layer suturing - three of the women died during the subsequent pregnancy and the fourth died from bleeding from the incision straight after the surgery. 

What’s scary is that a lot of hospitals then went on to only teach their residents single layer suturing as it was faster, easier, and saved 4-5 minutes per operation. A generation of doctors have only been taught single layer closure. 

This article in 2014 urges for a randomized trial to be performed as it says there is no evidence that a uterine rupture would not occur for the next pregnancy for a double layer suture patient wth the same circumstances. https://link.springer.com/article/10.1007/s13224-014-0573-9 

Lets have a look at some studies that were published since then:

Study 3 - https://www.ajog.org/article/S0002-9378(17)30370-8/fulltext

This study published in July 2017 looks at the impact on lower uterine segment thickness at next pregnancy. They had a sonographer measure the uterine muscle thickness of 1613 women recruited. where 495 (31%) had a single-layer and 1118 (69%) had a double-layer closure. These women were all at 34-38 weeks gestation and the study found that “Compared with single-layer closure, a double-layer closure of the uterus at previous cesarean delivery is associated with a thicker third-trimester lower uterine segment and a reduced risk of lower uterine segment thickness <2.0 mm in the next pregnancy.” They also looked at cat gut vs silk sutures but found that this had no significant impact on lower uterine segment thickness. A summary of the study is provided here: https://www.ncbi.nlm.nih.gov/pubmed/28263751 

Study 4 - https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-019-2221-y

The results from this study have not yet been published as the methodology was released in 2019. The study states however “In order to shorten surgery time and in the absence of significant differences in short-term outcomes [20, 21], most Dutch gynaecologists (92%) have replaced double-layer by single-layer closure after a CS, using multifilament continuous unlocked sutures. Given the higher risk on myometrium loss and thus development of a thinner residual myometrium after single-layer closure, we hypothesise that this method introduces a higher risk on postmenstrual spotting and possibly subfertility after a CS and that it can be prevented by applying double-layer unlocked closure.” 

Additionally, the study hypothesised that in the long term, double closure is still more cost effective than single closure due to the ongoing effects these women may experience “As we expect that double-layer closure will reduce the incidence of niche development and as a consequence that it could possibly reduce the gynaecological symptoms including postmenstrual spotting after CS, we assume double-layer closure to be more cost-effective. Also, we expect that double-layer closure will improve the chances of conceiving after CS and lower costs in fertility treatment.”

Have a look at this extract of an email sent by Ina Gaskin regarding single layer suturing: https://collegeofmidwives.org/collegeofmidwives.org/news01/VBAC%20gaskin01a.htm She discusses single vs double layer suturing, the evidence she’s personally seen of placenta percenta, and the lack of research on this new method. 

In summary 

I am not a medical professional, but I’ve read enough about experimental surgeries for it to seriously scare me. I truly believe that all women should be informed of the benefits and risks of any procedure or drug offered to them so that they can make an informed decision, and that before a new procedure is introduced, it should be adequately tested in a wide enough sample size to be approved internationally. That means not just testing the success of the one operation or procedure, but the impact it has on a number of variables that are highly likely for the patient. In this situation, a woman having a caesarean is highly likely to give birth again. It seems like the risk having a uterine rupture with a VBAC or placenta percenta with a Caesarean in subsequent births has not been considered as part of the testing and design phase of this method. This potential outcome should have been adequately considered and tested before the procedure was rolled out at so many hospitals around the world with no information given to their patients that this was a new procedure, departing from what was used successfully for the last 75 years.

Cover Image by Sasin Tipchai from Pixabay

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